UIC
researchers have launched the first scientific study to determine whether
two herbal medicines-black cohosh and red clover-are safe and effective
in treating symptoms of menopause.

Under
a five-year, $7.7 million grant from the National Center for Complementary
and Alternative Medicine at the National Institutes of Health, researchers
at the UIC College of Medicine will conduct two clinical trials.

The
first is a short-term toxicity study that builds on extensive research
done by the UIC College of Pharmacy to identify the herbs' active ingredients
and modes of action. The researchers will test the safety of six dosages
of black cohosh and red clover and examine how the human body metabolizes
the herbs. Patients are currently being recruited to participate in
the study.

The
second, and lengthier, clinical trial-to begin next year-will determine
whether the two herbs relieve menopausal symptoms such as hot flashes,
sleep and mood disturbances and sexual dysfunction. The researchers
will also examine whether the herbs provide any of the benefits of hormone
replacement therapy, such as retarding bone loss and lowering lipid
and cholesterol levels.

Although
studies have been conducted in Europe, none has met the "gold standard"
of scientific investigation used to design the UIC clinical trials,
according to co-investigators Stacie Geller, assistant professor of
obstetrics and gynecology, Suzanne Banuvar, manager of the trials, and
Dr. Richard Derman, professor of obstetrics and gynecology.

"More
and more women are turning to alternative nonprescription drugs, including
dietary supplements containing botanical ingredients, to alleviate menopausal
symptoms," said Derman. "However, these botanicals have not been uniformly
standardized. Their health benefits, as well as their risks, are largely
undetermined, particularly over long-term use."

In
the clinical trial to test the efficacy of the herbs, a total of 112
women will be randomly assigned to receive black cohosh, red clover,
a placebo or Prempro, a combined estrogen and progestin hormone replacement
drug. The trial will last a full year, long enough to minimize any placebo
effects, which generally occur during the first three to six months.
Neither the patients nor the investigators will know which of the four
test compounds each woman is receiving.

"We
are always looking for the perfect estrogen," said Geller, "one with
all the protective benefits of the hormone but none of its risks and
side effects."

Only
10 to 25 percent of postmenopausal women take hormone replacement therapy.
Although such drugs are widely prescribed in the United States, significant
numbers of women choose not to fill their prescriptions or discontinue
use of the medication within the first year.

According
to Geller, many women avoid taking these drugs because of the fear of
cancer or side effects, like breast tenderness and breakthrough bleeding.
Some women also prefer not to "medicalize" menopause, seeing it as a
natural outcome of aging.

Black
cohosh is a wildflower native to forests in North America. It was an
ingredient of Lydia Pinkham's Vegetable Compound, a patented remedy
for "female complaints" that was popular in the early 1900s. It has
been used for a variety of other purposes as well, for example, to treat
snakebites. Studies recently conducted in Europe suggest that the herb
can be used to treat menopausal symptoms, but none of the studies met
strict guidelines for clinical trials. The studies were too brief to
determine efficacy or safety; they were too limited in size and scope;
or women were not randomly assigned to patient and control groups.

Red
clover is a small perennial herb with fleshy red or white flowers that
is native to Europe, central Asia and northern Africa. It contains isoflavones,
which are being studied as possible agents to fight cancer. A few studies
have also suggested that isoflavones may help reduce vasomotor symptoms.

If
proven free of risks and side effects, as well as effective in alleviating
menopausal symptoms, these herbal treatments could offer women a number
of advantages over traditional hormone replacement therapy, the researchers
said.

For
more information on either UIC clinical trial, contact Suzanne Banuvar
at (312) 996-3333.